HealthyPhase 1NCT00726414
A Relative Bioavailability Study of Quinine Sulfate Capsules 324mg
A Phase 1 study testing Quinine Sulfate 2 x 324 mg Capsules in people with Healthy, run by Mutual Pharmaceutical Company, Inc..
Trial summary
The purpose of this study is to evaluate and compare the relative bioavailability of Quinine Sulfate capsules following a single, oral dose in healthy volunteers under fasting and fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Quinine Sulfate 2 x 324 mg Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Dec 2005
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Screening Demographics: All volunteers selected for this study will be healthy men and women 18 to 45 years of age at the time of dosing. Weight range will not exceed ±20% for height and body frame
- Screening Procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and human immunodeficiency virus (HIV) antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures
- Screening will include general observations, physical examination, demographics, medical history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems
- Screening Procedures:
- Hematology: hematocrit, hemoglobin, white blood cell (WBC) count with differential, red blood cell (RBC) count, platelet count
- Clinical chemistry: serum creatinine, blood urea nitrogen (BUN), glucose, AST(SGOT - Serum glutamic-oxaloacetic transaminase), ALT(SGPT - Serum glutamic-pyruvic transaminase), albumin, total bilirubin, total protein, and alkaline phosphatase
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- HIV antibody, hepatitis B surface antigen, hepatitis C antibody screens
- Urinalysis: by dipstick; full microscopic examination if dipstick positive; and
- Urine drug screen: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine
- Serum pregnancy screen (female volunteers only)
- If female and:
- of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condom with spermicide, diaphragm with spermicide, intrauterine device (IUD), or abstinence; or
- is postmenopausal for at least 1 year; or
- is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
Who cannot join
- Volunteers with a recent history of drug or alcohol addiction or abuse
- Volunteers with a presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by clinical investigators)
- Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant
- Volunteers demonstrating a reactive screen for hepatitis B surface antigen, hepatitis C antibody or HIV antibody
- Volunteers demonstrating a positive drug abuse screen when screened
- Female volunteers demonstrating a positive pregnancy screen
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- Female volunteers who are currently breastfeeding
- Volunteers with a history of allergic response(s) to quinine or related drugs
- Volunteers with a history of clinically significant allergies including drug allergies
- Volunteers with a clinically significant illness during the last 4 weeks prior to Period I dosing (as determined by the clinical investigators)
- Volunteers who report donating greater than 150 mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study
- Volunteers who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study
- Volunteers who report receiving any investigational drug within 28 days prior to Period I dosing
- Volunteers who report taking any systemic prescription medication in the 14 days prior to Period I dosing
- Volunteers who currently use tobacco products
- Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing
- Male volunteers with a corrected QT interval (QTc)> 430 milliseconds (msec)on the screening electrocardiogram (ECG) or with clinically significant findings
- Female volunteers with a QTC> 450 msec on the screening ECG or with clinically significant findings
About this study
Official title: A Relative Bioavailability Study of Quinine Sulfate Capsules 324mg Under Fasting and Fed Conditions
The purpose of this study is to evaluate and compare the relative bioavailability of Quinine Sulfate capsules following a single, oral dose in healthy volunteers under fasting and fed conditions.
Read the detailed description
The purpose of this study is to evaluate and compare the relative bioavailability of Quinine Sulfate capsules following a single, oral dose in healthy volunteers under fasting and fed conditions.
Twenty-two healthy, non-smoking, non-obese, male and female volunteers between the ages of 18 and 45 years of age will be randomly assigned in a crossover fashion to receive each of two Quinine Sulfate dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, subjects will receive either a single oral dose of Quinine Sulfate (2 x 324 mg capsules) following an overnight fast of at least 10 hours, or a single oral dose of Quinine Sulfate (2 x 324 mg capsules) 30 minutes after a standardized, high-fat breakfast. After a 7 day washout period, on the morning of Day 8, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 48 hours post-dose to adequately define the pharmacokinetics of Quinine Sulfate. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Blood pressure and heart rate will be measured prior to dosing and at 1, 2, 4 and 12 hours after each dose and at study exit. A 12 lead electrocardiogram (EKG) will be recorded at study check-in and at 2, 4, 6, 12 and 24 hours after dose administration. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the Investigator and reported in the subject's case report form.
- Conditions
- Healthy
- Being tested
- Quinine Sulfate 2 x 324 mg Capsules
- Keywords
- Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quinine Sulfate 2 x 324 mg CapsulesDrug
Quinine Sulfate (2 x 324 mg capsules) administered after an overnight fast of at least 10 hours.
Quinine Sulfate 2 x 324 mg CapsulesDrug
Quinine Sulfate (2 x 324 mg capsules) administered 30 minutes after a standardized, high fat breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Quinine Sulfate Capsules 2 x 324 mg Capsules - Fasting | Experimental | A single dose of Quinine Sulfate (2 x 324 mg capsules) administered after an overnight fast of at least 10 hours. Receives: Drug: Quinine Sulfate 2 x 324 mg Capsules |
| Quinine Sulfate Capsules 2 x 324 mg Capsules - Fed | Experimental | A single dose of Quinine Sulfate (2 x 324 mg capsules) administered 30 minutes after a standardized, high fat breakfast. Receives: Drug: Quinine Sulfate 2 x 324 mg Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) for Quinine Sulfate
The maximum or peak concentration that Quinine Sulfate reaches in the plasma.
Measured: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Quinine Sulfate
The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.
Measured: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] for Quinine Sulfate
The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.
Measured: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startDec 2005
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mutual Pharmaceutical Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726414
- Sponsor's protocol ID
- R05-1613
- Status last verified
- Jan 2010
- First submitted
- 30 Jul 2008
- Last updated
- 3 Feb 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Relative Bioavailability Study of Quinine Sulfate Capsules 324mg Under Fasting and Fed Conditions
- ClinicalTrials.gov ID
- NCT00726414
- Acronym / sponsor ID
- R05-1613
- Conditions
- Healthy
- Keywords
- Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Mutual Pharmaceutical Company, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 1 Aug 2008 (estimated)
- Results
- Posted 3 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate and compare the relative bioavailability of Quinine Sulfate capsules following a single, oral dose in healthy volunteers under fasting and fed conditions.
Detailed description
The purpose of this study is to evaluate and compare the relative bioavailability of Quinine Sulfate capsules following a single, oral dose in healthy volunteers under fasting and fed conditions.
Twenty-two healthy, non-smoking, non-obese, male and female volunteers between the ages of 18 and 45 years of age will be randomly assigned in a crossover fashion to receive each of two Quinine Sulfate dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, subjects will receive either a single oral dose of Quinine Sulfate (2 x 324 mg capsules) following an overnight fast of at least 10 hours, or a single oral dose of Quinine Sulfate (2 x 324 mg capsules) 30 minutes after a standardized, high-fat breakfast. After a 7 day washout period, on the morning of Day 8, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 48 hours post-dose to adequately define the pharmacokinetics of Quinine Sulfate. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Blood pressure and heart rate will be measured prior to dosing and at 1, 2, 4 and 12 hours after each dose and at study exit. A 12 lead electrocardiogram (EKG) will be recorded at study check-in and at 2, 4, 6, 12 and 24 hours after dose administration. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the Investigator and reported in the subject's case report form.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quinine Sulfate Capsules 2 x 324 mg Capsules - Fasting | Experimental | Drug: Quinine Sulfate 2 x 324 mg CapsulesA single dose of Quinine Sulfate (2 x 324 mg capsules) administered after an overnight fast of at least 10 hours. |
| Quinine Sulfate Capsules 2 x 324 mg Capsules - Fed | Experimental | Drug: Quinine Sulfate 2 x 324 mg CapsulesA single dose of Quinine Sulfate (2 x 324 mg capsules) administered 30 minutes after a standardized, high fat breakfast. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Screening Demographics: All volunteers selected for this study will be healthy men and women 18 to 45 years of age at the time of dosing. Weight range will not exceed ±20% for height and body frame
- Screening Procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and human immunodeficiency virus (HIV) antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures
- Screening will include general observations, physical examination, demographics, medical history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems
- Screening Procedures:
- Hematology: hematocrit, hemoglobin, white blood cell (WBC) count with differential, red blood cell (RBC) count, platelet count
Key exclusion criteria (18 listed)
- Volunteers with a recent history of drug or alcohol addiction or abuse
- Volunteers with a presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by clinical investigators)
- Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant
- Volunteers demonstrating a reactive screen for hepatitis B surface antigen, hepatitis C antibody or HIV antibody
- Volunteers demonstrating a positive drug abuse screen when screened
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quinine Sulfate 2 x 324 mg CapsulesQuinine Sulfate (2 x 324 mg capsules) administered after an overnight fast of at least 10 hours. | Drug | Quinine Sulfate Capsules 2 x 324 mg Capsules - Fasting |
| Quinine Sulfate 2 x 324 mg CapsulesQuinine Sulfate (2 x 324 mg capsules) administered 30 minutes after a standardized, high fat breakfast. | Drug | Quinine Sulfate Capsules 2 x 324 mg Capsules - Fed |
Primary outcome
Maximum Plasma Concentration (Cmax) for Quinine Sulfate
Time frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.
The maximum or peak concentration that Quinine Sulfate reaches in the plasma.
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Quinine Sulfate
Time frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.
The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] for Quinine Sulfate
Time frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.
The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Quinine Sulfate 2 x 324 mg Capsules in people with Healthy, run by Mutual Pharmaceutical Company, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) for Quinine Sulfate (time frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2010.